A Prospective, Non-Randomized, Multi-Center, Two-Arm Study Evaluating the Serene Sleep Palatal Implant System
Serene Sleep, Inc.
Summary
This clinical investigation is a prospective, non-randomized, parallel-group clinical investigation conducted at two (2) investigative sites. Study participants will be assigned to one of two study groups, snoring and obstructive sleep apnea, in a parallel manner based on predefined eligibility criteria. The study aims to evaluate and compare outcomes between the two groups under investigation. The primary endpoint for this study is to evaluate the adverse event profile of the Serene Sleep Palatal Implants, in comparison to those observed with the previously marketed Pillar Palatal Implants, in subjects treated for snoring and/or mild-to-moderate OSA. The design allows for the concurrent enrollment and follow-up of participants in both arms, enabling direct observation of differences in safety across the groups over time.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA A potential participant must meet ALL the following criteria to be enrolled into this study: 1. Participant is ≥18 years of age. 2. Participant has Body Mass Index (BMI) less than or equal to 30 kg/m² 3. Participant has a tonsil grade less than or equal to 2 4. Participant has a Friedman Tongue Position (FTP) I or II 5. Participant is able to provide voluntary written informed consent. For a snoring participant to be selected for the study: * Confirmed identification of palatal snoring * Investigators will utilize standard of care clinical assessment methods to confir…
Interventions
- DevicePalatal Implant System
Serene Sleep Palatal Implant System
Locations (2)
- Aesthetic Surgery CenterSan Francisco, California
- Augusta ENTEvans, Georgia